Adverse drug reactions (ADRs) in hospitalized pediatric patients. A prospective study.

The aim of this study was to determine the frequency and the characteristics of ADRs in 219 hospitalized pediatric patients, using an intensive and prospective drug surveillance method. The frequency of ADRs in these patients was 13.7%. The systems most commonly affected were the gastrointestinal (32.5%), the central nervous (20.0%), and the metabolic systems (17.5%). Asparaginase, methotrexate, phenytoin, phenobarbital, erythromycin, and salbutamol were probably the drugs associated with the ADRs. According to causality, 54.2% of the ADRs were regarded as probable, and 32.2% as possible. The majority of the ADRs were moderate (51.2%), 27.9% were severe. The main treatment of the ADRs was the withdrawal of the suspected drugs. The length of the stay in the hospital and the total number of drugs given to the patients influenced significantly the frequency of ADRs. 93% of the ADRs were dose-dependent.